FDA

Sample Response to FDA Tobacco Warning Letter

No One-Size-Fits-All Approach, No Sample Response to a FDA Tobacco Warning Letter Getting a FDA Warning Letter for your tobacco…

FDA Consultant Food Services

Our FDA Consultant Food and Beverage Services are comprehensive, to help our clients develop products that are compliant with federal…

FDA Untitled Letters: FDA Warnings with a Twist

The U.S. Food and Drug Administration (“FDA”) has recently been issuing letters to companies that are distinct from traditional FDA…

FDA Regulation of Aromatherapy and Essential Oil Products

Aromatherapy and essential oil products are becoming more popular by the day, and marketing these products in compliance with federal…

Cosmetic Products and the FDA

FDA Regulation of Cosmetics Products Importers introducing cosmetic products into the United States must be mindful of FDA regulations, which…

FDA Imports: Tradeoff — Less Vigilance for More Diligence

The U.S. Food and Drug Administration (FDA) has found its ability to inspect and re-inspect all of the entities involved…

District Court sides with Industry on Dietary Supplement Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held…

FDA Clears Device via De Novo Process

On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling…

FDA “Natural” Food Labeling

On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the…

What’s in a Name? Everything, for “Standard” FDA Food Labeling

FDA Particular words mean everything to the U.S. Food and Drug Administration (FDA).  It takes great pains and uses specific…